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DPP4 Inhibitor Intervention on Post-stroke Cognitive Impairment in Ischemic Stroke Patients With Type 2 Diabetes Phase III 312 Randomisé Double aveugle Contrôlé par placebo
Les détails de l'essai clinique sont principalement disponibles en anglais. Cependant, l'IA Trial Radar peut vous aider ! Cliquez simplement sur 'Expliquer l'étude' pour voir et discuter des informations sur l'étude dans la langue sélectionnée.
L'essai clinique NCT07241897 est conçu pour étudier le traitement de Accident vasculaire cérébral ischémique, Diabète sucré. Il s'agit d'une étude interventionnel en Phase III. Son statut actuel est : pas encore en recrutement. Le recrutement est prévu pour commencer le 15 décembre 2025, avec un objectif de 312 participants. Dirigée par Second Affiliated Hospital of Soochow University, l'étude devrait être terminée d'ici le 30 avril 2028. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 21 novembre 2025.
Résumé succinct
Post-stroke cognitive impairment (PSCI) increases the risk of disability and mortality in stroke patients, thereby exacerbating the disease burden of stroke. Type 2 diabetes is a major risk factor for PSCI, and stroke patients with type 2 diabetes have a higher risk of developing PSCI. Despite the high incidence and severe impact of PSCI, effective intervention methods are still lacking. Identifying safe and effectiv...Afficher plus
Titre officiel
DPP4 Inhibitor on Post-stroke Cognitive Impairment in Ischemic Stroke Patients With Type 2 Diabetes Mellitus (DISC-DM): Multicentre, Double Blind, Randomised, Placebo Controlled Trial
Pathologies
Accident vasculaire cérébral ischémiqueDiabète sucréPublications
Articles scientifiques et travaux de recherche publiés sur cet essai clinique:Autres identifiants de l'étude
- LC2024019
- 82471226 (Autre financement) (the National Natural Science Foundation of China)
Numéro NCT
Date de début (réel)
2025-12-15
Dernière mise à jour publiée
2025-11-21
Date de fin (estimée)
2028-04-30
Inscription (estimée)
312
Type d'étude
Interventionnel
PHASE
Phase III
Statut
Pas encore en recrutement
Mots clés
DPP4 inhibitors
Ischemic Stroke
PSCI
Diabetes Mellitus
RCT
Ischemic Stroke
PSCI
Diabetes Mellitus
RCT
Objectif principal
Traitement
Méthode d'allocation
Randomisé
Modèle d'intervention
Parallèle
Masquage
Triple aveugle
Bras / Interventions
| Groupe de participants/Bras | Intervention/Traitement |
|---|---|
ExpérimentalIntervention Group Sentagliptin Phosphate 50 mg, once daily, plus metformin hydrochloride extended-release tablets (50 mg, two or three times daily). If blood glucose is still not well-controlled, sulfonylurea drugs may be added as needed. | Sentagliptin Phosphate - single dose Sentagliptin Phosphate 50 mg, once daily, plus metformin hydrochloride extended-release tablets (50 mg, two or three times daily). If blood glucose is still not well-controlled, sulfonylurea drugs may be added as needed. |
Comparateur placeboControl Group Placebo (identical in size, shape, color, appearance, and odor to Sentagliptin Phosphate, 50 mg, once daily) plus metformin hydrochloride extended-release tablets (50 mg, two or three times daily). If blood glucose is still not well-controlled, sulfonylurea drugs may be added as needed | PLACEBO Placebo (identical in size, shape, color, appearance, and odor to Sentagliptin Phosphate, 50 mg, once daily) plus metformin hydrochloride extended-release tablets (50 mg, two or three times daily). If blood glucose is still not well-controlled, sulfonylurea drugs may be added as needed. |
Critère principal d'évaluation
Critère secondaire d'évaluation
| Critères d'évaluation | Description de la mesure | Période |
|---|---|---|
Change in MoCA score before and after the 180-day intervention | Change in MoCA score before and after the 180-day intervention | 180 days |
| Critères d'évaluation | Description de la mesure | Période |
|---|---|---|
PSCI incidence at 180 days | MoCA score \< 25 | 180 days |
Changes in MMSE score and scores in various cognitive domains before and after the 180-day intervention | Changes in MMSE score and scores in various cognitive domains before and after the 180-day intervention | 180 days |
Changes in MoCA and MMSE scores before and after the 90-day intervention | Changes in MoCA and MMSE scores before and after the 90-day intervention | 90 days |
Modified Rankin Scale (mRS) score and cardiovascular and cerebrovascular events at 90 and 180 days | Modified Rankin Scale (mRS) score and cardiovascular and cerebrovascular events at 90 and 180 days | 90 days and 180 days |
Assistant à la participation
Critères d'éligibilité
Âges éligibles
Adulte, Adulte âgé
Âge minimum
40 Years
Sexes éligibles
Tous
- Mild ischemic stroke, defined as a National Institutes of Health Stroke Scale (NIHSS) score ≤ 5.
- Coexisting type 2 diabetes with a disease duration of less than 5 years.
- Ability to complete the MoCA, MMSE, and the NINDS-CSN-recommended 1-hour standardized neuropsychological test for VCI.
- Age between 40 and 75 years.
- Onset of stroke within the last 2 weeks.
- Glycated hemoglobin (HbA1c) between 6.5% and 8.5%.
- More than 9 years of education.
- Informed consent signed by the patient or their family.
- Coexisting dementia or severe cognitive impairment (MoCA < 17).
- Coexisting severe depression, defined as a Hamilton Depression Rating Scale (HAMD) score ≥ 20.
- Prior use of cognitive-enhancing drugs, such as donepezil or memantine.
- Allergy to DPP4 inhibitors.
- Past or current use of DPP4 inhibitors.
- Past or current use of GLP-1 agonists.
- Type 1 diabetes, latent autoimmune diabetes in adults, secondary diabetes, malignant tumors, autoimmune diseases, or other endocrine-related diseases.
- Moderate or severe liver or kidney dysfunction.
- Chronic or acute pancreatitis.
- Pregnancy or lactation.
- Severe infection or severely impaired immune response.
- Participation in other clinical trials.
- Past or current use of insulin therapy.
Second Affiliated Hospital of Soochow UniversityPartie responsable de l'étude
yifang zhu, Investigateur principal, Professor, Second Affiliated Hospital of Soochow University
Contact central de l'étude
Contact: Shoujiang You, MD, PhD, +8615995738506, [email protected]
Contact: WenYan Hua, MD, 0512-67783682, [email protected]
1 Centres de l'étude dans 1 pays
Jiangsu
Department of Neurology, Second Affiliated Hospital of Soochow University, Suzhou, Jiangsu, 215004, China
Shoujiang You, MD, PhD, Contact, 00 86 512 67783662, [email protected]
Yongjun Cao, MD, PhD, Contact, 00 86 512 67784789, [email protected]